510(k) K931297 ยท KPS System, Tomography, Computed, Emission
GCA-7200A
| Applicant | Toshiba America Medical Systems, In.C, Tustin CA, US |
| Decision | Substantially Equivalent, Jul 27, 1993 |
| Received | Mar 15, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K931297
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Toshiba American Med Sys Inc Pinhole Collimator (NDCL709A) for Digital Gamma Cameras GCA-7100A series and CGA-7200A series.
Regulation Number 21 CFR 892.1200, Class 2 device, . Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.